The pharmaceutical industry is one of the most highly regulated fields in the world. From initial development to federal approval, every part of drug production must follow proper protocol as established by a federal authority such as the U.S. Federal Drug Administration (FDA) or the EU’s European Medicines Agency. Beyond regulating drug production, approval, and usage, these governing bodies also have stringent requirements regarding pharmaceutical product packaging. 

Regulations like the FDA’s Drug Supply Chain Security Act and Federal Trade Commission's Fair Packaging and Labeling Act compel drug producers to include certain information on all of their product packaging. Some of this information (e.g. directions for use, health risks, active ingredients, expiration dates, manufacturer title/location, etc.) is required to inform consumers on how to safely use the product. Other mandatory markings, such as barcodes, data matrices, QR codes, packaging dates, and serial numbers, are fundamental to creating complete supply chain traceability. Without these markings, companies can be subject to expensive fines, reputation-damaging penalties, and widespread product recalls. 

To avoid these steep consequences, pharmaceutical packaging companies need to use reliable marking equipment that can:

1. Code products moving at industrial speeds, often around 1000 feet per minute.
2. Prevent coding mistakes through reliable construction.

However, choosing coding technologies for pharmaceutical applications isn’t always easy. The market is filled with hardware, software, and printing consumable options that can overwhelm consumers. 

To help alleviate potential confusion, we have profiled how to select the best product option regarding three categories—software solutions, thermal transfer overprinters, and laser marking systems. Here’s what you need to know.

1. Software Solutions

Utilizing high-quality software helps companies streamline their marking processes, improve code quality, and reduce the potential for errors. Software solutions provide these benefits through complete IT system integration. By pulling product information from a centralized database, marking software eliminates the possibility of potential misprints by ensuring that all label codes are accurate. 

This system integration also greatly reduces the need for data entry. Modern software solutions like Domino Cloud, QuickDesign, and CLARiSUITE enable operators to remotely control all of their hardware. Without this interconnection, operators would need to individually populate templates and create action items on every single printer or laser system across their plant. 

As such, when searching for a software solution for your pharmaceutical operation, select an option that provides:

• Complete IT infrastructure connectivity.
• The ability to aggregate serialized data.
• Real-time updates on potential problems and equipment effectiveness.
• The ability to automatically generate GS1-compliant codes.

2. Thermal Transfer Overprinters

Thermal transfer overprinting (TTO) is the go-to marking option for placing label information on pharmaceutical products. Thermal transfer overprinters create codes by melting ink ribbons onto flexible films and surfaces. Through high-precision melting, TTO machines can create high-resolution codes that are sharp and easy to read.

TTO is a versatile printing method that is compatible with a variety of flexible materials and paper types. The direct contact printhead utilized by TTO machines is well-suited for wide format printing, making it ideal for large barcodes, alphanumerics, and icons/branding. 

When selecting a thermal transfer overprinter, it’s important to examine the specs to ensure that the model can meet your production line speeds and print to the required resolution. It’s also best practice to find a model that can maintain ribbon tension for extended periods. With ideal tension, line operators can:

• Eliminate downtime.
• Increase coding efficiency.
• Save money on ribbon replacements.

3. Laser Marking Systems

Laser marking systems are one of the most versatile coding technologies for pharmaceutical applications. Compatible with a wide range of packaging types, including bottles, tubes, blister packs, cartons, cases, metal vials, and paper labels, laser systems use infrared light beams to leave clear marks on substrate surfaces. As a contact-free coding method, laser systems can also easily handle curved surfaces that traditionally complicate marking operations.

With a laser marking system, line operators can precisely code packages moving at hundreds of meters per minute. As laser systems don’t require ink to create codes , operators save significant money on printing consumables as well.

If you are looking to integrate a laser marking system into your line, consider the following:

• Beam quality: The higher the beam quality and the better the concentration of the laser energy, the quicker the system can leave a mark. If you are seeking a system to code metal materials, a high-quality beam is a must. Less laser energy may be required for those looking to code plastic or labels, but beam quality will always affect the speed and crispness of the mark achieved. TEM00 is the optimal beam quality a laser should always produce. The laser system you choose should have this rating for laser beam output.
  
• Mark resolution: All systems vary in how high their code resolutions can reach. Codes that only require human readability do not need to be significantly high-resolution, whereas machine-readable codes (e.g. data matrices, QR codes, barcodes, etc.) require a high DPI resolution.
  
• Beam steering method: Laser systems use different methods to steer their direct beams. Although these techniques will invariably use mirrors to steer the laser beam, the control of the mirror movement and the focal length of the focusing option will differ. Consequently, certain systems will excel at marking substrates from particular angles while others will be restricted. It is best practice to personally consult with an expert to ensure that your packaging types will be compatible with whichever laser models you are considering. 

Choosing Coding Technologies for Pharmaceutical Applications Can Be Tough

There’s a lot to consider when establishing a pharmaceutical marking system. All software solutions and hardware options have their pros and cons, with varying quality based on the manufacturer. Fortunately, consulting with an expert can help narrow your focus and reveal which options will work best for your line.

At C&M Digest, we contribute to this by continually reviewing the latest marking solutions and providing in-depth coverage on the biggest brands in the industry. C&M Digest will keep you informed with the most important industry insights from ink formula guides to market forecasts.

For more tips on choosing coding technologies for pharmaceutical applications, stay connected with C&M Digest by subscribing to our newsletter. To get in touch with us about possible collaborations or ideas for coverage, contact us today.